BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KURIN BLOOD CULTURE COLLECTION SET

    MDR report key: 21428807 · Received February 20, 2025

    Report

    Report Number
    3013696225-2025-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 21, 2025
    Report Date
    January 24, 2025
    Manufacturer
    KURIN INC
    Product Code
    JKA
    PMA / PMN Number
    K191832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNDETERMINED, THE AFFECTED DEVICES WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    KURIN BUTTERFLY NEEDLE SYSTEM USED X3 IN ATTEMPT TO OBTAIN BLOOD CULTURES FROM PATIENT (PT.), EACH TIME THE NEEDLE AUTO-RETRACTED WITHOUT BUTTON BEING TOUCHED WHEN PARAMEDIC WAS ATTEMPTING BLOOD DRAW. LOT NUMBER FOR ALL 3 IS 8618-051324-F1 AND SAME EXPIRATION DATE OF 2026-05-13. RESULTED IN UNNECESSARY POKES FOR LABS FOR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269184 KURIN BLOOD CULTURE COLLECTION SET TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA KURIN INC TJ-221 8618-051324-F1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other